A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC

An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B Associated Hepatocellular Carcinoma

An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma

Study Overview

• Status: Completed
• Conditions: Hepatitis B Associated Hepatocellular Carcinoma
• Intervention / Treatment: Drug: clevudine, Adefovir

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Patient with chronic HBV DNA and/or with symptoms of liver cirrhosis
2. Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
3. Patient is 18 years and older.

4. Patient is documented to be HBsAg positive for > 6 months.

   • Laboratory report proving HBsAg positive or HBeAg positive for at least six months
   • IgM anti-HBc negative, IgG anti-HBc positive at screening
5. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
6. Patient has ALT or AST levels >=40 IU/L
7. Cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year.
8. Patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
9. Patient who is classified as NYHA functional classification grade 1-2. (NYHA;New York Heart Association)
10. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria

1. Patient is currently receiving antiviral therapy.
2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with metastatic malignancy.
6. Patient with previous liver transplantation
7. Patient is pregnant or breast-feeding.
8. Patient has a clinically relevant history of abuse of alcohol or drugs.
9. Patient use oriental medicine within the previous 2 weeks.
10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with HBV DNA levels < 60 IU/mL	48 week

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 17, 2010
• First Posted (Estimate): December 20, 2010

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Liver Neoplasms; Carcinoma; Hepatitis B; Hepatitis; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Adefovir; Clevudine
• Other Study ID Numbers: CLV-413